Cobe Spectra Blood Component Separator Therapeutic
FDA 510(k) K900105 · Cobe Laboratories, Inc.
510(k) numberK900105
Submission
- Device name
- Cobe Spectra Blood Component Separator Therapeutic
- Applicant
- Cobe Laboratories, Inc.
Lakewood, CO, US - Received
- January 9, 1990
- Decision date
- March 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKN – Separator, Automated, Blood Cell And Plasma, Therapeutic
- Device class
- Unclassified
Other 510(k)s with product code LKN
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| K183081 | Spectra Optia Apheresis SystemLKN · Traditional | Terumobct, Inc. | 02/05/2019SE |
| K180615 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood…LKN · Traditional | Fresenius Kabi USA,Llc | 12/04/2018SE |
| K181049 | Spectra Optia Apheresis SystemLKN · Special | Terumobct, Inc. | 11/01/2018SE |
| K172590 | Spectra Optia Apheresis SystemLKN · Traditional | Terumobct, Inc. | 03/02/2018SE |
| K153601 | Spectra Optia Apheresis SystemLKN · Special | Terumobct, Inc. | 01/14/2016SE |
| K151368 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra…LKN · Traditional | Terumo Bct | 09/11/2015SE |
| K141938 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)LKN · Traditional | Terumobct, Inc. | 03/23/2015SE |
| K141019 | Amicus Separator System/ Amicus Seperator System;RefurbishedLKN · Traditional | Fenwal, Inc. | 06/10/2014SE |
| K132429 | Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange…LKN · Traditional | Terumobct, Inc. | 12/06/2013SE |
More from Terumobct, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923272 | Cobe Cms-Hf Hollow Fiber Membrane OxygenatorDTZ · Traditional | 05/11/1993SE |
| K905793 | Cobe Centry 2 Bicart Option KitFKP · Traditional | 02/12/1991SE |
| K905388 | Cobe Centrysystem 3 Bicart Option KitFKP · Traditional | 02/11/1991SE |
| K904336 | New Cobe Saturation/Hematocrit MonitorGKF · Traditional | 12/27/1990SE |
| K902631 | Cobe ICU Conversion KitDTN · Traditional | 12/17/1990SE |
| K902437 | Cobe Cardiotomy Reservoir with or Without FilterDTP · Traditional | 12/17/1990SE |
| K904566 | New Cobe Centrysystem(Tm) 100 HG DialyzerFJI · Traditional | 12/12/1990SE |
| K902758 | Cobe Saturation/Hematocrit Monitor W/ Fiber OpticDQA · Traditional | 08/23/1990SE |
| K902759 | Cobe Closed Wound Drainage KitCAC · Traditional | 07/18/1990SE |
| K902671 | Cobe Autologous Blood Salvage Reserv W/W/O FilterCAC · Traditional | 07/17/1990SE |
Questions and answers
When was Cobe Spectra Blood Component Separator Therapeutic cleared by the FDA?
Cobe Spectra Blood Component Separator Therapeutic (K900105) received a 510(k) decision of Substantially Equivalent on March 22, 1991, 437 days after the submission was received.
What is the product code of K900105?
The FDA product code is LKN – Separator, Automated, Blood Cell And Plasma, Therapeutic, a Unclassified device.